NDC codes

FDA NDC Directory
Product NDC (as listed)47335-929Labeler and product segments. Claims need a package NDC.
Product NDC at billing width47335-0929Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
47335-929-21473350929211 BOTTLE in 1 CARTON (47335-929-21) / 14 CAPSULE in 1 BOTTLEMarketed from Feb 13, 2014
47335-929-724733509297215 BLISTER PACK in 1 CARTON (47335-929-72) / 1 CAPSULE in 1 BLISTER PACKMarketed from Feb 13, 2014
47335-929-74473350929745 BLISTER PACK in 1 CARTON (47335-929-74) / 1 CAPSULE in 1 BLISTER PACKMarketed from Feb 13, 2014
47335-929-754733509297520 BLISTER PACK in 1 CARTON (47335-929-75) / 1 CAPSULE in 1 BLISTER PACKMarketed from Feb 13, 2014
47335-929-80473350929801 BOTTLE in 1 CARTON (47335-929-80) / 5 CAPSULE in 1 BOTTLEMarketed from Feb 13, 2014
47335-929-87473350929871 BOTTLE in 1 CARTON (47335-929-87) / 20 CAPSULE in 1 BOTTLEMarketed from Feb 13, 2014

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Temozolomide
Generic name (nonproprietary)
temozolomide
Active ingredients
Temozolomide — 140 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201742
Marketing start
Listing expires
Other FDA classes
Alkylating Activity (Mechanism)
Identifiers
Product ID 47335-929_7c774570-443b-40da-8038-7cb550f92048SPL ID 7c774570-443b-40da-8038-7cb550f92048SPL set ID c1e05c21-a411-4493-80de-ede373632475RxCUI 313209, 313210, 313211, 317160, 700883, 700885UNII YF1K15M17Y
Pharmacologic class
Alkylating Drug

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N447335092921 followed by a unit qualifier and the quantity

Package 47335-0929-21. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Temozolomide is an alkylating drug indicated for the treatment of adults with: • Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1) • Anaplastic astrocytoma. (1.2) o Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2) o Treatment of adults with refractory anaplastic astrocytoma. (1.2) 1.1 Newly Diagnosed Glioblastoma Temozolomide capsules are indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment. 1.2 Anaplastic Astrocytoma Temozolomide capsules are indicated for the: • adjuvant treatment of adults with newly diagnosed anaplastic a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 47335-929

What is NDC 47335-929?
47335-929 is the product NDC for Temozolomide, Temozolomide 140 mg/1 capsule, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Temozolomide.
What is the active ingredient?
Temozolomide.
Who is the labeler?
Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Temozolomide?
63 other product NDCs are listed under this name. See all Temozolomide NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Temozolomide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TemozolomideTemozolomide 100 mg/1CapsuleOralOPKO Pharmaceuticals, LLC70301-200570301-2005-0170301-2005-02
TemozolomideTemozolomide 140 mg/1CapsuleOralOPKO Pharmaceuticals, LLC70301-200770301-2007-0170301-2007-02
TemozolomideTemozolomide 180 mg/1CapsuleOralOPKO Pharmaceuticals, LLC70301-200970301-2009-0170301-2009-02
TemozolomideTemozolomide 250 mg/1CapsuleOralOPKO Pharmaceuticals, LLC70301-201170301-2011-01
TemozolomideTemozolomide 20 mg/1CapsuleOralCivicaScript LLC82249-40682249-0406-0582249-0406-14
TemozolomideTemozolomide 5 mg/1CapsuleOralCivicaScript LLC82249-40482249-0404-0582249-0404-14
TemozolomideTemozolomide 180 mg/1CapsuleOralCivicaScript LLC82249-41282249-0412-0582249-0412-14
TemozolomideTemozolomide 100 mg/1CapsuleOralCivicaScript LLC82249-40882249-0408-0582249-0408-14
TemozolomideTemozolomide 140 mg/1CapsuleOralCivicaScript LLC82249-41082249-0410-0582249-0410-14
TemozolomideTemozolomide 250 mg/1CapsuleOralCivicaScript LLC82249-41482249-0414-05

All 64 Temozolomide NDCs

Other NDCs under ANDA 201742

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 201742
ProductStrengthForm · routeLabelerProduct NDC
TemozolomideTemozolomide 250 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.47335-893
TemozolomideTemozolomide 5 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.47335-890
TemozolomideTemozolomide 20 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.47335-891
TemozolomideTemozolomide 100 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.47335-892
TemozolomideTemozolomide 180 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.47335-930

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